| CTRI Number |
CTRI/2024/10/075392 [Registered on: 16/10/2024] Trial Registered Prospectively |
| Last Modified On: |
20/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Impact of Manual Physiotherapy in Frozen Shoulder |
|
Scientific Title of Study
|
Effect of MET (Muscle Energy Technique) and Mulligan Mobilization with movement on patient suffering from Frozen Shoulder: A Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Puja Kumari |
| Designation |
MPT Student |
| Affiliation |
Jaipur National University |
| Address |
Department of Physiotherapy, JNU Hospital, Ghati Karolan, Jagatpur, Jaipur
Jaipur
RAJASTHAN
302017
India |
| Phone |
9649784338 |
| Fax |
|
| Email |
pujasharmaphysio.02@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Puja Kumari |
| Designation |
MPT Student |
| Affiliation |
Jaipur National University |
| Address |
Department of Physiotherapy, JNU Hospital, Ghati Karolan, Jagatpur, Jaipur
RAJASTHAN
302017
India |
| Phone |
9649784338 |
| Fax |
|
| Email |
pujasharmaphysio.02@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Puja Kumari |
| Designation |
MPT Student |
| Affiliation |
Jaipur National University |
| Address |
Department of Physiotherapy, JNU Hospital, Ghati Karolan, Jagatpur, Jaipur
RAJASTHAN
302017
India |
| Phone |
9649784338 |
| Fax |
|
| Email |
pujasharmaphysio.02@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
JNU Hospital |
| Address |
Department of Physiotherapy, JNU Hospital, Ghati Karolan, Jagatpura, Jaipur |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Himanshu Mathur |
JNU Hospital |
Room No. 3, Orthopedics Lab, Department of Physiotherapy, JNU Hospital, Ghati Karolan, Jagatpura, Near New RTO, Jaipur
Jaipur
RAJASTHAN |
9649784338
drhimanshumathur5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe (IEC) JNUIMSRCe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Frozen Shoulder |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Manual Therapy |
Posterolateral glide manual therapy of the Glenohumeral Joint to be given for 6 days per week as 10 repetition in 2 sets per session |
| Comparator Agent |
Muscle Energy Technique |
Muscle Energy Technique of Internal and External rotator muscle of the glenohumeral joint to be given for 6 days per week as 6 seconds hold 10 repetition in 3 sets per session |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Unilateral Frozen Shoulder |
|
| ExclusionCriteria |
| Details |
Arthritis cervical radiculopathy trauma |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Range of Flexion, Abduction, Internal and External Rotation motion by Goniometry |
Day 0 to Day 21 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pain by Visual Analogue Scale
Function by Shoulder Pain And Disability Index (SPADI)
Distance between Acromion and plinth by Vernier Calliper |
Day 0 to Day 21 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="21" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A common musculoskeletal disorder known as frozen shoulder (FS) is
characterized by limited active and passive range of motion (ROM), persistent
discomfort, and impairment. People with this ailment trouble with simple
everyday activities like clothing, taking care of themselves, moving above, and
sleeping patterns. The condition can range from mild to severe pain and from
minimal to severe movement restriction. Study collate and summarise individual studies contains information
about effectiveness of Muscle energy technique (MET), Mulligan Mobilization
with Movement (MWM) along with Conventional Exercise Regime on Patient
suffering from Frozen shoulder. Methods: 30
subjects diagnosed with Unilateral Frozen shoulder will be randomly divided in two groups of 15 each. In this randomized controlled trial (RCT) patients
with diagnosis of frozen shoulder will be administered with MET, MWM in group A & B (n = 15). The shoulder pain and disability index (SPADI),
Goniometric assessment of shoulder ROM and distance of acromion from plinth by
vernier calliper will be taken as outcome measure. |